510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1581
Chemistry
355
Dental
1270
Ear, Nose, Throat
233
Gastroenterology & Urology
920
General & Plastic Surgery
2106
General Hospital
1837
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
924
Obstetrics & Gynecology
419
Ophthalmic
265
Orthopedic
2677
Pathology
49
Physical Medicine
506
Radiology
2289
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
377
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Baxano, Inc.
Medical Device Manufacturer
·
US , Yorba Linda , CA
Baxano, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2007
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baxano, Inc.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 07, 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696
·
ETN
Ear, Nose, Throat
·
115d
Cleared
Oct 02, 2009
BAXANO NEURO CHECK DEVICE
K092729
·
ETN
Ear, Nose, Throat
·
28d
Cleared
Sep 17, 2008
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
K081742
·
ETN
Ear, Nose, Throat
·
90d
Filters
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10
Neurology
6
Ear, Nose, Throat
3
Anesthesiology
1